IN PROGRESS - LF Common Case Report Form (CCRF)
LF has been working on creating a Common Case Report Form (CCRF) with the goals of having a CRF to use in the LF Biobank, having more standardized data collection amongst LF awardees in 2026 and beyond, and to publish online as a resource to the field of Lipedema.
Steps involved in CCRF development:
Began with a rough list of elements to collect from Box 4 (page 24) of the Lipedema Research Roadmap (included input from > 60 stakeholders)
Created a Common Data Element (CDE) database, pulled from as many published sources as possible
Reviewed with trusted clinicians, researchers, and patients
Configured in REDCap Cloud and did extensive internal and external user testing
Piloted the CCRF at an LF Biobank recruitment event in March 2025 at the FDRS conference in Atlanta, with 74 participants and 3 diagnosing clinicians
Engaged an external biostatistician to analyze pilot data and recommend CCRF CDE refinements
Currently categorizing the CDEs into four categories: Core, Supplemental - Highly Recommended, Supplemental, and Exploratory.
We want to hear from you
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At this stage in our field’s development, clinicians and investigators do not always agree on precise diagnostic criteria. We expect that variation across countries and groups will persist for some time. This is expected and acceptable, as long as teams collect and report data in comparable ways.
Consistent capture of diagnostic factors, comorbidities, and other data will allow the field to:
Assess the applicability of findings from individual studies
Compare results across studies
Conduct rigorous meta-analyses
Conduct retrospective analyses to understand which factors matter most for diagnosis
Identify and classify meaningful subtypes
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One of the highest priority recommendations from the Lipedema Research Roadmap was the creation of a common case report form to be used across the field. LF and collaborators have been working hard toward advancing this recommendation.
Steps taken so far include:
Began with a rough list of elements to collect from Box 4 (page 24) of the Lipedema Research Roadmap (included input from > 60 stakeholders)
Created a CDE database, pulled from as many published sources as possible
Reviewed with trusted clinicians, researchers, and patients
Configured in REDCap Cloud and did extensive internal and external user testing
Piloted the CCRF at an LF Biobank recruitment event in March 2025 at the FDRS conference in Atlanta, with 74 participants and 3 diagnosing clinicians
Engaged an external biostatistician to analyze pilot data and recommend CCRF CDE refinements
Refined the CCRF CDEs to incorporate feedback and statistical analysis
Current and near-future steps
Categorize individual CDEs as Core, Supplemental - Highly Recommended, Supplemental, and Exploratory (now)
Publish the full CRF (“v1”) on LF’s website (by end 2025)
Submit a methods paper manuscript about the Common CRF and this process to Frontiers in Cell and Developmental Biology special edition "Molecular and Cellular Mechanisms in Lipedema: Advancing Understanding for Therapeutic Development.”
Collect feedback through an open comment platform (ongoing)
Once this work is complete, we will begin using the CCRF at LF Biobank clinical sites and for LF-funded projects. We will also encourage broad use by, and feedback from, the entire field.